Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04936867
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The CArdiac Imaging RegistrY Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2 year', 'description': 'number of deaths'}, {'measure': 'Survival', 'timeFrame': '5 year', 'description': 'number of deaths'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease (CAD)']}, 'descriptionModule': {'briefSummary': 'In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.\n\nParticular aims include:\n\n1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models\n2. To determine associations between CAD severity and plaque type and:\n\n 1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)\n 2. blood markers of increased cardiovascular risk\n3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)\n4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).', 'detailedDescription': 'Particular aims include:\n\n1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models\n2. To determine associations between CAD severity and plaque type and:\n\n 1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)\n 2. blood markers of increased cardiovascular risk\n3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)\n4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults referred to clinical cardiac computertomography imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (=/\\>18 years of age)\n2. Able to provide informed consent\n3. Clinical indication for cardio-CT in line with the latest clinical guidelines\n\nExclusion Criteria:\n\n1. standard contraindications to CT (in line with local roles and guidelines - please see Appendix)\n2. known allergy to iodinated contrast agent\n3. suspected acute kidney injury\n4. unstable hemodynamic status or arrhythmias\n5. suspected acute coronary syndrome\n6. manifest thyrotoxicosis'}, 'identificationModule': {'nctId': 'NCT04936867', 'acronym': 'CARYSMA', 'briefTitle': 'The CArdiac Imaging RegistrY Study', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety', 'orgStudyIdInfo': {'id': 'CARYSMA Registry Study 466/16'}}, 'contactsLocationsModule': {'locations': [{'zip': '60596', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Institute for experimental and translational cardiovascular imaging', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Valentina Puentmann', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}